Archive: VIDEO: Doctors bucking Lyme protocols

Patients are receiving longer courses of antibiotics for Lyme disease than guidelines recommend, a survey finds. A variety of antibiotics are prescribed, depending on the patient's response and illness.(Photo: Spencer Ainsley/Poughkeepsie Journal)Buy Photo

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A federal study that concluded there are likely 300,000 Lyme disease cases annually, a tenfold rise from official reports and an acknowledgment of the illness' reach across America.

Research indicates that nearly 4 million Americans have had Lyme disease.

A majority of Lyme disease patients are being treated with antibiotics for longer than government-endorsed guidelines recommend, a sign doctors may be rejecting controversial protocols in favor of patients who remain ill after receiving them, new government data obtained by the Poughkeepsie Journal show.

The revelation comes from a federal study that concluded there are likely 300,000 Lyme disease cases annually, a tenfold rise from official reports and an acknowledgment of the illness' reach across America.

But the study — consisting of three public surveys and separate analyses of insurance bills and lab tests — uncovered other startling, and undisclosed, Lyme disease trends, the Journal found. The research indicates that nearly 4 million Americans have had Lyme disease, giving details on who they are and how they fared.

The study was announced in a news release in August, when only the new case estimate was released — a figure patient advocates think may still be low. Though the study was taxpayer-funded, the U.S. Centers for Disease Control and Prevention declined to release it as "preliminary." A key CDC official, Ben Beard, expressed displeasure in an email to patient advocates that posters summarizing the data, given to them and shown at a recent conference, had been provided to the Journal. (See the posters at www.poughkeepsiejournal.com)

Thousands surveyed

The mid-Hudson Valley has among the nation's highest rates of the tick-borne illness, with five local counties placing in the top 10 per capita, the latest national figures from 2002 to 2006 show.

As part of the study, three public surveys on Lyme disease were conducted, in 2009, 2010 and 2012. The findings:

• In one survey, 36 percent of people diagnosed with Lyme disease were treated with antibiotics for more than eight weeks — twice the time that treatment guidelines recommend — and 20 percent were treated for five to eight weeks. The 2009 survey profiled 60 of 4,728 people who reported suffering from Lyme.

• About 1.25 percent of 8,231 people surveyed reported ever having had Lyme disease, which the Journal computed was about 3.9 million people nationwide.

"(O)ur findings from these nationally representative surveys suggest that a very large number of individuals in the U.S. have been diagnosed" with Lyme disease, the researchers wrote. Survey sizes were "robust," they wrote, in order to ensure "representativeness."

Among Lyme sufferers was a significant share of children, the insurance data show. The largest group hospitalized for Lyme disease was 5 to 9 years old, offering a possible explanation of the lower education rates among people who said they had chronic Lyme. Many parents have told of children missing long stretches of schooling due to Lyme disease. The average age of 17 chronic Lyme sufferers identified by surveyors was 30, versus 51 for all respondents.

1 in 20 not treated

Though the case estimate was the only news officially released from the CDC study, the most compelling revelation may be that physicians appear to be treating Lyme disease based on their experience rather than solely on the Infectious Diseases Society of America's guidelines. Patient advocates say the Lyme spirochete can survive treatment protocols to become chronic, while the guidelines hold that the Lyme pathogen is almost always killed off with no more than 28 days of antibiotics.

But just 39 percent of Lyme patients reported being treated within the guidelines, or for four weeks or less. Fully 56 percent were treated longer, while 5 percent said they were not treated at all. The longer treatment regimens and revised higher case count heartened Lyme patient advocates who long have challenged Lyme treatment theories.

"This is a whole new ballgame," said Dr. Elizabeth Maloney, a Minnesota physician and published researcher who conducts continuing-education courses on Lyme disease. She said doctors have told her, in response to the revised figure, "Well, what else do we have wrong?"

The CDC and Infectious Diseases Society issued similar statements expressing dismay at the longer treatments.

"These findings confirm that health care providers are not rigidly following the IDSA guidelines and underscore the need for more education of providers regarding best treatment practices," wrote Paul Mead, CDC epidemiology chief in the bacterial diseases branch.

Diana Olson, the diseases society's spokeswoman, said, "The use of long-term antibiotic therapy does not reflect best practices and may be a result of inaccurate information being provided for how physicians should treat Lyme disease."

Mead cited potential dangers of prolonged oral and intravenous antibiotic treatment and "non-antibiotic therapies," maintaining that "patients diagnosed with 'chronic Lyme disease' have died as a direct result of inappropriate treatment." The CDC had no figure on deaths but referred a reporter to a 2000 article in the journal Clinical Infectious Diseases on one; a 30-year-old woman died from an infection related to intravenous antibiotic treatment for "unsubstantiated" Lyme disease, it reported.

Death reported

On the other side, Lyme physicians say the disease itself is risky. It was listed as a cause in 114 deaths from 1999 to 2003, according to a 2010 article in the same medical journal that disputed all but one of the death certificates. And it was linked last week to the Aug. 5 death of a 17-year-old Poughkeepsie High junior who was found to have "disseminated" Lyme disease. The exact cause of death is pending.

"It is an unpredictable illness," said Dr. Kenneth Liegner, a Pawling physician who disputes the CDC-endorsed treatment guidelines. "It is a dangerous infection."

Dr. Richard Horowitz, a Hyde Park physician who treats long-term Lyme disease, said a 2011 medical journal article concluded the society's guidelines were based in part on "opinion," so that "doctors should not use them as the sole source guiding patient decisions."

"Based on that analysis," he said, "many doctors choose not to follow the IDSA guidelines, and treat for longer periods of time."

Like Horowitz, other physicians and patient advocates suggested the new estimate of 300,000 was low, believing standard Lyme lab tests fail to diagnose many cases and that the disease exists in unrecognized areas like the South.

"I think this is probably a low-end number," Maloney said. "Because many patients are not diagnosed with Lyme when they should be … they end up seeing providers who don't take insurance. Thus, there's no way to find and count these patients."

At the heart of the issue is testing accuracy both in early and later stages, advocates said.

"Published studies put the sensitivity" — accuracy for correctly testing positive — "at 70 percent, at best," said Holly Ahearn, associate professor of microbiology at State University of New York, Adirondack, and Lyme researcher. So the new estimate, she suggested, "is therefore only 70 percent of the actual number of cases." A better figure might be 400,000, she said.

On early Lyme cases, Mead said the calculations were corrected to account for many patients who he acknowledged will "test falsely negative."

High response rates

The case figure was derived largely from a study of lab tests performed by seven large testing companies in 2008, which put the number of positive cases that year at 312,000.

But in the 2012 public survey, 0.3 percent of respondents reported having Lyme disease within the prior year, which would amount to about 900,000 cases nationwide that year. But while the three surveys employed large samples and had high response rates – 80 percent, or 3,503, responded in 2012 — the number of Lyme cases recorded was just 10, according to the survey abstract.

CDC officials noted that Lyme diagnoses were self-reported and researchers did not give a definition to respondents; they said it would be "inappropriate" to extrapolate results from such a small sample. Some Lyme advocates agreed, while maintaining the true count was likely between the two figures.